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Jun 30, 2020
Inozyme Q2 2020 Earnings Report
Inozyme Pharma reported financial results for the second quarter ended June 30, 2020 and provided recent business highlights.
Key Takeaways
Inozyme Pharma reported a net loss of $9.5 million for the second quarter ended June 30, 2020. The company completed an upsized initial public offering in July 2020, raising $128.8 million in gross proceeds. They also submitted an IND for INZ-701 for the treatment of ENPP1 deficiency, which is currently on FDA clinical hold.
Completed upsized Initial Public Offering in July 2020, raising $128.8 million in gross proceeds.
Submitted an IND for INZ-701 for the treatment of ENPP1 deficiency; currently on FDA clinical hold pending completion of ongoing GLP toxicology studies.
Initiation of INZ-701 Phase 1/2 clinical trials anticipated in early 2021, as previously planned.
Acquired ENPP1 program assets from Alexion Pharmaceuticals in July 2020.
Forward Guidance
Inozyme expects to submit reports in Q4 2020 and initiate clinical program in early 2021.
Positive Outlook
- Expects to submit toxicology reports in the fourth quarter of 2020.
- Plans to initiate Phase 1/2 trials in early 2021.
- Anticipates reporting initial safety and biomarker data in 2021.
- Existing cash, cash equivalents and short-term investments, including the proceeds from its July 2020 IPO, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2022.
- FDA did not request any additional preclinical data to resolve the clinical hold other than the submission of the final study report for the three-month GLP toxicology studies in mice and NHPs.
Challenges Ahead
- IND for INZ-701 placed on clinical hold pending submission of final study report for toxicology studies.
- Clinical trial of INZ-701 in adult patients with ENPP1 deficiency in the United States on clinical hold.
- Requires successful resolution of the clinical hold to initiate Phase 1/2 trials.
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